WO2003041622A2 - Dispositifs de mise en place d'implants de regulation de flux - Google Patents

Dispositifs de mise en place d'implants de regulation de flux Download PDF

Info

Publication number
WO2003041622A2
WO2003041622A2 PCT/US2002/033557 US0233557W WO03041622A2 WO 2003041622 A2 WO2003041622 A2 WO 2003041622A2 US 0233557 W US0233557 W US 0233557W WO 03041622 A2 WO03041622 A2 WO 03041622A2
Authority
WO
WIPO (PCT)
Prior art keywords
delivery device
implant
wire
tube
trigger
Prior art date
Application number
PCT/US2002/033557
Other languages
English (en)
Other versions
WO2003041622A3 (fr
Inventor
Oded Nissan
Sagi Ben-Rimon
Ira Yaron
Original Assignee
Optonol Ltd.
Werner, Mary, C.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Optonol Ltd., Werner, Mary, C. filed Critical Optonol Ltd.
Priority to AU2002335865A priority Critical patent/AU2002335865A1/en
Publication of WO2003041622A2 publication Critical patent/WO2003041622A2/fr
Publication of WO2003041622A3 publication Critical patent/WO2003041622A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment

Definitions

  • the invention relates generally to delivery devices for delivering and/or implanting flow regulating implants, which are medical implants used to regulate the flow of fluids within the body.
  • the delivery devices may be used, for example, to deliver and/or implant ophthalmic flow regulating implants which are used for the treatment of glaucoma.
  • Glaucoma is an eye condition characterized by an increase in the intraocular pressure (IOP) of the eye to an abnormal level.
  • IOP intraocular pressure
  • a normal eye maintains a proper IOP by the circulation within the eye of aqueous humor ⁇ aqueous humor is secreted from the ciliary body, passes through the pupil into the anterior chamber of the eyeball, and is filtered out of the eyeball via the trabeculum and the Canal of Schlemm.
  • Glaucoma With glaucoma, the aqueous humor excretory pathway is blocked, the aqueous humor cannot pass out of the eyeball at an adequate rate, the IOP rises, the eyeball becomes harder, and the optic nerve atrophies by the pressure applied on its fibers leaving the retina. A characteristic optic neuropathy develops, resulting in progressive death of the ganglion cells in the retina, restriction of the visual field, and eventual blindness. Advanced stages of the disease are characterized also by significant pain. Glaucoma treatment, if initiated early in the course of the disease, can prevent further deterioration and preserve most of the ocular functions. The goal of glaucoma treatment is to reduce the IOP to a level which is considered safe for a particular eye, but which is not so low as to cause ocular malfunction or retinal complications.
  • glaucoma treatment is filtration surgery, which provides an alternate route for aqueous humor to exit the anterior chamber of the eyeball and enter the sub-conjunctival space, thereby lowering the IOP.
  • filtration surgery provides an alternate route for aqueous humor to exit the anterior chamber of the eyeball and enter the sub-conjunctival space, thereby lowering the IOP.
  • full thickness operations a fistula is created through the limbal sclera, connecting directly the anterior chamber of the eyeball and the sub-conjunctival space.
  • Full thickness operations provide long-lasting control of IOP; however, excessive loss of aqueous humor from the eyeball during the early postoperative period frequently leads to hypotony.
  • a fistula created through the limbal sclera is protected by an overlying partial thickness sutured scleral flap.
  • the scleral flap provides additional resistance to excessive loss of aqueous humor from the eyeball, thereby reducing the risk of early postoperative hypotony.
  • trabeculectomy may result in higher eventual IOP and increased risk of late failure of filtration, compared with full thickness operations.
  • a full thickness filtering fistula may be created by a holmium laser probe, with minimal surgically induced trauma.
  • a conjunctival incision (approximately 1 mm) is made about 12-15 mm posterior to the intended sclerostomy site, and a laser probe is advanced through the sub-conjunctival space to the limbus. Then, multiple laser pulses are applied until a full thickness fistula is created.
  • This technique has sometimes resulted in early hypotony on account of a difficulty in controlling the sclerostomy size, hi addition, early and late iris prolapse into the sclerostomy has resulted in abrupt closure of the fistula and eventual surgical failure. Further, despite its relative simplicity, the technique still necessitates the use of retrobulbar anesthesia to avoid pain caused by the laser applications. The injection of anesthetic material close to the already damaged optic nerve may sometimes lead to further visual damage. A further disadvantage of this procedure, as well as other types of glaucoma filtration surgery, is the propensity of the fistula to be sealed by scarring.
  • Typical ophthalmic implants utilize drainage tubes so as to maintain the integrity of the openings formed in the eyeball for the relief of the IOP.
  • Figure 28 illustrates a distal end portion of a delivery device 110.
  • the delivery device 110 has a handle (not shown) and a rodlike instrument in the form of a tube 112.
  • the tube 112 has a central bore 114 in which is located a retractable wire 116.
  • the retractable wire 116 is positioned for penetrating a tube passage 102 of the implant 100 when the implant 100 is attached to the delivery device 110.
  • the delivery device 110 has a retention mechanism including an abutment surface 118 having an angle generally corresponding to that of a flange or disk 106 of the implant 100, for preventing the implant 100 from moving up the delivery device 110 during implantation, and a hook 120 for preventing the implant 100 from moving down the wire 116.
  • the angled abutment surface 118 also prevents the implant 100 from rotating relative to the delivery device 110.
  • the implant 100 is placed over the wire 116 with the wire 116 projecting into the tube passage 102 and with the abutment surface 118 abutting against the flange or disk 106, with the hook 120 retaining the flange or disk 106 around the opposite side.
  • Figure 28 illustrates the distal end of the delivery device 110 in this condition, with the retention wire 116 in its forward position.
  • FIG. 29 of U. S . Patent No. 6,203 ,513 illustrates the end of the delivery device 110 with the retention wire 116 retracted. With the retention wire 116 retracted, the implant 100 is free to slide away from the hook 120, allowing the delivery device 110 to be withdrawn, leaving the implant 100 in place.
  • the delivery devices may be used, for example, to deliver and implant ophthalmic implants, which may be implanted into the eyeball for the treatment of glaucoma.
  • An example of a delivery device within the scope of the invention comprises a handle and a tube (such as a hollow needle or cannula), with a retractable wire extending through the tube.
  • a tube such as a hollow needle or cannula
  • the drainage implant is mounted on the wire at the distal end of the tube; for example, the implant may have a central bore into which the wire extends.
  • the implant may be held on the wire by friction, by a hook, or by other suitable means.
  • the delivery device includes a trigger that acts on the retractable wire. Actuating the trigger retracts the wire into the tube, thereby releasing the implant. With such a construction, the physician can easily deliver the implant to the appropriate site. When implant is in place, pressing the trigger releases the implant from the delivery device such that the implant can be left in place and the delivery device can be withdrawn.
  • the handle may have a holding area that includes notches designed for improving grip.
  • the holding area may have a triangular or other suitable cross-sectional profile that provides the user with the ability to control the orientation of the delivery device as the implant is inserted.
  • the handle may be similar in length to other tools employed by ophthalmologists.
  • the handle may be designed such that the user can operate the device with either hand.
  • the distal end of the tube may be configured for cooperation with the implant.
  • the distal end of the tube may be angled to match an angled disk or flange on the implant.
  • the implant in prevented from rotating relative to the delivery device.
  • the physician is able to know the position of the implant from knowing the position of the delivery device.
  • the implant may be oriented on the delivery device such that the implant is in the correct position for implantation if the trigger is facing away from the eye, or if the trigger is facing up.
  • the wire may extend all the way through the tube of the delivery device.
  • the proximal end of the wire may be adhered or otherwise rigidly connected to the handle.
  • the trigger may act on a portion of the wire that is between the proximal end of the tube and the area where the wire is adhered or connected to the handle.
  • Features may be incorporated to prevent undesired actuation of the trigger.
  • a removable safety wedge may be used to prevent movement of the wire until the wedge is removed.
  • a suitable distance may be provided between the holding area and the trigger, such that the delivery device may be maneuvered simply by holding the holding area, and not the trigger.
  • delivery devices according to the invention may be designed to be disposable and incapable of multiple uses.
  • An example of a method for implanting an ophthalmic implant with a delivery device according to the invention may start with cutting a small slit in a portion of the conjunctiva which normally lies at a distance away from the intended implantation site.
  • the slit also may be very small. The small size of the slit, as well as its positioning at a distance away from the implantation site, helps prevent contamination of the sclerostomy site and reduces the risk of infection.
  • the physician may then use the delivery device to place the implant through the slit, to direct it to the implantation site, and to insert it into the sclera at the implantation site.
  • the sclera may be pierced by the tip of the implant.
  • the physician may then press the trigger to retract the wire and release the implant.
  • the action of the trigger may occur in three stages, which allows the user to control the timing and the release rate of the implant.
  • the initial movement is an idle movement that permits the user to push the trigger down easily.
  • the next stage moves the wire through its elastic strain range and slightly retracts the wire from the implant, thereby beginning the releasing process.
  • the wire is forced into a notch in the handle, fully retracting the wire into the tube and fully releasing the implant.
  • An implant delivery device has other applications aside from the field of intraocular implants.
  • the implant delivery device maybe used to delivery and insert an implant for drainage of a hydrocele sac, regulating flow between the hydrocele sac and the subcutaneous scrotum.
  • other applications in accordance with the invention are possible.
  • Figure 1 is an isometric view of a delivery device according to the invention
  • Figure 2 is a side view of the delivery device of Figure 1;
  • Figure 2A is an illustrative cross-sectional view, taken along the line A-A in Figure 2, of the holding area of the handle of the delivery device shown in Figure 1;
  • Figures 3 A through 3D illustrate the actuation of the trigger of the delivery device of Figure 1, with the consequent retraction of the wire.
  • FIGS 1 and 2 illustrate isometric and side views, respectively, of an example of a delivery device 210.
  • the delivery device 210 comprises a handle 222 and a tube 212, with a retractable wire 216 extending through the tube 212.
  • the wire 216 Prior to deployment, the wire 216 extends a short distance out of the distal end 213 of the tube 212.
  • a drainage implant may be mounted on the wire 216 at the distal end 213 of the tube 212.
  • the distal end 213 of the tube 212 has an abutment surface that is angled to match an angled flange or disk on the implant.
  • the abutment surface also prevents the implant from moving up the delivery device 210 during implantation, hi this embodiment, the implant is held on the wire 216 by a friction fit, which prevents the implant from moving down the wire 216.
  • This embodiment does not have a hook, although a hook may alternatively be used, as in Figures 28 and 29 of U.S. Patent No. 6,203,513. With the friction fit, the hook is optional.
  • the handle 222 has a holding area 224 that includes notches 226 designed for improving grip. As shown in Figure 2A, the holding area 224 has a generally triangular cross-sectional profile, which provides the physician with the ability to control the orientation of the delivery device 210, and thus the orientation of the implant.
  • the wire 216 extends all the way through the tube 212. The proximal end of the wire 216 may be adhered or otherwise rigidly connected to the handle, for example at wire attachment area 228.
  • the delivery device 210 includes a trigger 230 that acts on the retractable wire 216. Pressing the trigger 230 retracts the wire 216 into the tube 212, thereby releasing the implant.
  • the trigger 230 is configured as a resilient spring, biased in the non-actuated position as shown in Figures 1 and 2. Pressing the trigger 230 causes a contact portion 232 of the trigger 230 to engage a portion of the wire 216 that is between the proximal end 211 of the tube 212 and the wire attachment area 228, where the wire is adhered or connected to the handle 222.
  • a removable safety wedge 234 may be used to prevent movement of the wire 216 until the wedge 234 is removed. The wedge 234 may be removed just prior to use of the delivery device 210, or just prior to actuation of the trigger 230.
  • the physician may then press the trigger 230 to retract the wire 216 and release the implant.
  • the action of the trigger 230 may occur in three stages, which allows the user to control the timing and the release rate of the implant.
  • the initial movement occurs between the relaxed position shown in Figure 3A and the position shown in Figure 3B. This initial movement is an idle movement that permits the user to push the trigger 230 down easily, without movement of the wire 216. In this manner, the physician can control the proper pressure on the trigger, which allows the physician to control the distance to which the trigger is depressed.
  • the next stage which occurs from the position shown in Figure 3B to the position shown in Figure 3C, moves the wire 216 through its elastic strain range and slightly retracts the wire 216 from the implant, thereby beginning the releasing process.
  • the wire 216 is forced into a notch 236 in the handle 222, fully retracting the wire 216 into the tube 212 and fully releasing the implant.
  • the end of the wire 216 maybe retracted into the tube 212 further than the distal end 213 of the tube, to insure that the wire 216 will not come out of the tube 212 when the trigger 230 is released.
  • the retractable wire 116 in a delivery device such as that illustrated in Figures 28 and 29 of U.S. Patent No. 6,203,513 may be retracted by action of an actuating mechanism or trigger in accordance with the present invention.
  • the actuating mechanism or trigger may take any suitable form, for example as shown in the embodiment of Figures 1 through 3.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne des dispositifs de mise en place d'implants de régulation de flux comprenant une poignée et un tube (tel qu'une canule ou une aiguille creuse), un fil rétractable s'étendant à travers le tube. Avant déploiement, le fil s'étend sur une faible distance à l'extérieur au niveau de l'extrémité distale du tube. L'implant de régulation de flux est monté sur le fil à l'extrémité distale du tube. L'implant peut par exemple présenter un orifice central dans lequel passe le fil. L'implant peut être maintenu par frottement, par un crochet, ou par d'autres moyens appropriés. Le dispositif de mise en place comprend un système de déclenchement qui agit sur le fil rétractable. L'actionnement du système de déclenchement retire le fil dans le tube, ce qui provoque le relâchement de l'implant.
PCT/US2002/033557 2001-11-13 2002-10-22 Dispositifs de mise en place d'implants de regulation de flux WO2003041622A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002335865A AU2002335865A1 (en) 2001-11-13 2002-10-22 Delivery devices for flow regulating implants

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/987,134 2001-11-13
US09/987,134 US20030093084A1 (en) 2001-11-13 2001-11-13 Delivery devices for flow regulating implants

Publications (2)

Publication Number Publication Date
WO2003041622A2 true WO2003041622A2 (fr) 2003-05-22
WO2003041622A3 WO2003041622A3 (fr) 2003-08-28

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PCT/US2002/033557 WO2003041622A2 (fr) 2001-11-13 2002-10-22 Dispositifs de mise en place d'implants de regulation de flux

Country Status (3)

Country Link
US (1) US20030093084A1 (fr)
AU (1) AU2002335865A1 (fr)
WO (1) WO2003041622A2 (fr)

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